A Study About Nutritional Support of Enhanced Protein in Critical Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Critical Illness

Treatments: Dietary Supplement: basic energy intake; Dietary Supplement: maltodextrin; Dietary Supplement: a production consist of various oligopeptides and the whey protein

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04177446

HS-2028

Details and patient eligibility

About

This is a prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status, safety indicators and clinical indicators.

Full description

Critical illness patients are commonly in the risk of malnutrition, because of various factors. And nutritional supplement, particularly the supplement of protein, can decrease the nitrogen balance, improve the nutritional status, accelerate the speed of healing and decrease the mortality rate. This is a multi center prospective randomized controlled trial. 180 patients with critical illness will be included and randomly divided into two groups. In the control group, patients will be fed with basic energy; and in the experiment group, the patients will be given extra protein intake except the basic energy intake. The intervention duration will last 6 days. The primary outcomes of this study are urea nitrogen of 24h and prealbumin(PA). And other outcomes include nutritional status(total protein, albumin, grip and calf circumference), safety indicators(liver function, kidney function, tolerance, etc.) and clinical indicators(overall complication rate, length of hospital stay and cost).

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed as critical illness, stayed in ICU;
2. score of M-nutric ≥ 5;
3. score of 3. APACHE Ⅱ >12;
4. anticipation of length of hospital stay > 6 days;
5. 18 ≤ age ≤ 45;
6. pattens volunteer to attend this study and sigh the inform consent form;

Exclusion criteria

1. liver function(AST/ALT) of blood test ≥ 2.5 ULN(upper limit of normal); renal function of blood test > 1.6 ULN;
2. the patients are used or are planned to use the Human Albumin solution within 3 days before receiving enteral nutrition;
3. consume any natural food or something made by natural food;
4. patients are used or are planned to use all-in-one solution or amino acid solution within 3 days before receiving enteral nutrition;
5. anticipation of survival time is less than 5 days;
6. have the contraindications of enteral nutrition;
7. patients are allergic to material of the production;
8. patients who are considered not suitable for this study by investigators;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

Patients will be given basic energy intake according to their weight, and will be extra maltodextrin as the placebo

Treatment:

Dietary Supplement: maltodextrin

Dietary Supplement: basic energy intake

intervention group

Experimental group

Description:

Patients will be given basic energy intake according to their weight, and will be extra protein intake

Treatment:

Dietary Supplement: basic energy intake

Dietary Supplement: a production consist of various oligopeptides and the whey protein